MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number UNK OMNILINK ELITE

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problem Aneurysm (1708)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

B3: date of event ¿ estimated.D4: the unique device identifier (udi) is unknown because the part number and lot number were not provided.D6a: date of implant ¿ estimated.H6- device code 1494 clarifier: incorrect anatomy.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Literature attachment: title - percutaneous duplication of the thoracic aorta in a child: part 2.The other omnilink elitestent referenced in b5 is filed under separate medwatch report number.

Event Description

It was reported through a research article, identifying the omnilink stent that may be related to: stent migration, stenosis and additional intervention.The patient, with a history of history of severe aortic coarctation, underwent surgical implantation of a non-abbott bypass shunt at the age of 2.At the age of 9, the patient underwent magnetic resonance imaging which showed complete occlusion of the native aorta and stenosis of the bypass at its proximal insertion.Two 10 mm omnilink stents were implanted, overlapping, to achieve recanalization of the native aorta.An additional 10mm omnilink stent was implanted at the proximal portion of the bypass.The article noted that the patient height was 130 cm and weight was 29 kg at the time of the procedure.Three years post procedure, the patient underwent computed tomography which showed proximal migration of the upper omnilink stent and loss of the overlap between the two omnilink stents (previously overlapping) in the native aorta.Additionally, a large aneurysm was present.The article noted that, at this time, the patient height was 155 cm and weight was 42 kg.The patient underwent cardiac catheterization and a single non-abbott covered stent was implanted to exclude the aneurysm.The proximal stented portion of the bypass was dilated using a non-abbott dilatation catheter balloon.The conclusion of the article was that some interventions on children's growing structures should not be consider as definitive and require careful follow up to detect possible complications requiring treatment.Details are listed in the attached article, titled percutaneous duplication of the thoracic aorta in a child: part 2.Please see article for additional information.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot numbers were not provided.It was reported that two 10 mm omnilink stents were implanted, overlapping, to achieve recanalization of the native aorta.An additional 10mm omnilink stent was implanted at the proximal portion of the bypass.It should be noted that the omnilink elite instructions for use (ifu), states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions.It is possible that the ifu deviation caused/contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported stent migration.The reported patient effect of aneurysm is listed in the omnilink elite ifu as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect of aneurysm, and the relationship to the product, if any, cannot be determined.The subsequent unexpected medical intervention (additional therapy/non-surgical treatment) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17065662
• MDR Text Key: 316573425
• Report Number: 2024168-2023-05914
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK OMNILINK ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 9 YR
• Patient Weight: 29 KG